Ventricular Tachycardia (VT)NCT06745778
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
An observational study of Ventricular Tachycardia (VT) and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in China.
Trial summary
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT), Ventricular Fibrillation
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 26 Feb 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study selected two study site in China. One is a Tertiary A hospital in Zhejiang Province, and another is a hospital in Shanghai. Both of the two sites locate in south east of China. This study will enroll around 50 subjects who meet the inclusion and exclusion criteria from the ICD or CRT-D patients who have received LBBAP in the two hospitals.
Who may be able to join
- Patients aged >=18 yrs.
- Patients indicated for ICD or CRT-D (primary or secondary prevention)
- Patients who recently (<=30 days) received ICD/CRT-D implantation with LBBP
- Patients' EGM can be digitally recorded
- Patients are willing to participate in the study and provide signed informed consent
Who cannot join
- Patients received CIED upgrade or replacement with old pacing leads
- Patients are pregnant
- Patients participate in another study that will confound this study
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Tongren Hospital
Shanghai, 200025
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:
- Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICD or CRT-D patients who have received LBBP implantation | Patients' EGMs can be recorded by Holter DR220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
R-wave amplitude of LBB EGM
Amplitude in millivolt
Measured: At the enrollment, 3 months after enrollment and 6 months after enrollment
Secondary outcomes (1)
EGM morphology-LVAT
LVAT in millisecond, calculated based on electrogram recorded by LBB lead
Measured: At the enrollment, 3 months after enrollment and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start26 Feb 2025
- Primary completion18 Aug 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745778
- Sponsor's protocol ID
- LBBP-ICD study
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ponnusamy SS, Ramalingam V, Ganesan V, Syed T, Kumar M, Mariappan S, Murugan S, Basil W, Vijayaraman P. Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study. Heart Rhythm O2. 2022 Dec 16;3(6Part B):723-727. doi: 10.1016/j.hroo.2022.08.004. eCollection 2022 Dec.
PubMed 36589004
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
- ClinicalTrials.gov ID
- NCT06745778
- Acronym / sponsor ID
- LBBP-ICD study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:
- Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD or CRT-D patients who have received LBBP implantation | – | –Patients' EGMs can be recorded by Holter DR220 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study selected two study site in China. One is a Tertiary A hospital in Zhejiang Province, and another is a hospital in Shanghai. Both of the two sites locate in south east of China. This study will enroll around 50 subjects who meet the inclusion and exclusion criteria from the ICD or CRT-D patients who have received LBBAP in the two hospitals.
Key inclusion criteria (5 listed)
- Patients aged >=18 yrs.
- Patients indicated for ICD or CRT-D (primary or secondary prevention)
- Patients who recently (<=30 days) received ICD/CRT-D implantation with LBBP
- Patients' EGM can be digitally recorded
- Patients are willing to participate in the study and provide signed informed consent
Key exclusion criteria (3 listed)
- Patients received CIED upgrade or replacement with old pacing leads
- Patients are pregnant
- Patients participate in another study that will confound this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
R-wave amplitude of LBB EGM
Time frame: At the enrollment, 3 months after enrollment and 6 months after enrollment
Amplitude in millivolt
1 secondary outcome
EGM morphology-LVAT
Time frame: At the enrollment, 3 months after enrollment and 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Results publication: PubMed 36589004Ponnusamy SS, Ramalingam V, Ganesan V, Syed T, Kumar M, Mariappan S, Murugan S, Basil W, Vijayaraman P. Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study. Heart Rhythm O2. 2022 Dec 16;3(6Part B):723-727. doi: 10.1016/j.hroo.2022.08.004. eCollection 2022 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia (VT) and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R-wave amplitude of LBB EGM (time frame: At the enrollment, 3 months after enrollment and 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06745778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.